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Zirconium-89-girentuximab PET/CT imaging in patients suspected of primary or relapse clear cell renal cell carcinoma: The impact on clinical decision making

Zirconium-89-girentuximab PET/CT imaging in patients suspected of primary or relapse clear cell renal cell carcinoma: The impact on clinical decision making - Zirconium-89-girentuximab PET/CT imaging in renal cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42374
Enrollment
30
Registered
2015-10-14
Start date
2015-12-11
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cancer

Interventions

Administration of 5 mg/37 MBq zirconium-89-girentuximab followed by PET/CT after 4 days.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: His or her clinician should face a diagnostic dilemma; - patients with a renal mass of unknown origin, or - patients with a primary renal mass in whom it is unclear whether there is metastatic disease, or - patients with a history of clear cell RCC with a suspicion of relapse or metastatic disease. * Age over 18 years;Signed informed consent

Exclusion criteria

Exclusion criteria: History of a CAIX-negative or non clear cell RCC. Administration of tyrosine kinase inhibiters within 1 month prior to inclusion. Known hypersensitivity or HACA against Girentuximab.

Design outcomes

Primary

MeasureTime frame
Impact on clinical decision making, defined as present or absent: * Absent: e.g. no change in treatment or follow-up * Present: e.g. change in follow-up schedule, change in surgical technique, be more certain of your treatment strategy, change from surgery to active surveillance, or change from surgery to systemic treatment.

Secondary

MeasureTime frame
The amount of biopsies or surgery that are prevented by zirconium-89-girentuximab PET/CT. *

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)